infoTECH News

[January 28, 2014]

Provectus Announces PV-10's Assessment for Drug-Drug Interaction Potential is Subject of Article Published by Xenobiotica

KNOXVILLE, Tenn. --(Business Wire)--

Provectus Biopharmaceuticals, Inc. (OTCQB:PVCT) (http://www.pvct.com),
a development-stage oncology and dermatology biopharmaceutical company,
and XenoTech, a preclinical CRO and pioneer in collaborative research
surrounding in vitro drug metabolism and pharmacokinetics (DMPK)
services, today announced that an article describing a study to
determine the potential of rose bengal disodium to cause drug-drug
interactions has been published by Xenobiotica, a peer-reviewed
scientific journal that publishes comprehensive research papers on
pharmacokinetics (the study of distribution, metabolism, disposition and
excretion of drugs). The published research indicated that the risk of
PV-10 causing clinically relevant drug-drug interactions is likely
minimal. PV-10, a 10% solution of rose bengal that is currently under
clinical investigation as a novel cancer therapeutic, is designed to
selectively target and destroy cancer cells without harming surrounding
healthy tissue, minimizing the potential for systemic side effects.

The study was undertaken prior to initiation of the now ongoing testing
of PV-10 plus sorafenib (cohort 2) in a clinical trial of PV-10
intralesional injection in hepatocellular carcinoma patients taking a
stable dose of sorafenib (ClinicalTrials.gov
Identifier: NCT00986661). Sorafenib is a competitive inhibitor of
cytochrome P450 (CYP) drug metabolism enzymes and is reliant on the
UDP (News - Alert)-glucuronosyltransferase (UGT) pathway for efficient clearance. CYP
and UGT enzymes help to biotransform small lipophilic drugs like
sorafenib into water-soluble excretable metabolites.

Provectus researchers collaborated with XenoTech's experts to design the
appropriate in vitro experiments necessary to assess the risk for
potential liability when rose bengal is co-administered with other drugs
in humans. Rose bengal, known for inducing singlet oxygen on exposure to
light, can cause erroneous results in conventional in vitro test
systems. These assay artifacts were shown to be test system dependent in
DMPK studies. XenoTech scientists successfully tailored experiments to
ascertain CYP and UGT inhibition potential in more appropriate model
systems.

The lead author, Faraz Kazmi, a Senior Scientist at XenoTech said "The
FDA guidance for industry on drug-drug interactions requires an in
vitro assessment of the potential liability for a new drug to
engender drug-drug interactions. These experiments are important because
they provide the basis for safe, rational clinical trial design and are
important determinants toward the ultimate goal, which is patient
safety."

Dr. Craig Dees, PhD, CEO of Provectus said, "We were thrilled to
collaborate with XenoTech on these important studies that not only
support the PV-10 plus sorafenib study, but also have implications for
treating melanoma patients. Provectus has been fortunate to work with
many CROs with innovative scientists, but Xenotech stands out for their
focus on the unique scientific problem as demonstrated in their rapid,
expert assay development, suitable for publication in a peer reviewed
journal." Dr. Dees continued, "As we discuss our clinical results with
regulatory authorities, we continue to be intensely committed to
building all sections of the prescribing information for a future
package insert for PV-10."

Jason Neat, COO of XenoTech said, "We are very pleased with the
expertise shown by our scientists. Rose bengal presented a unique
challenge, but we rose up to meet that challenge and showed what
XenoTech as a company is all about. Our customers get rapid results, but
they also receive the context to be assured that those results will be
meaningful in their development programs."

XenoTech is a Contract Research Organization with unparalleled
experience and expertise in evaluating drug candidates as substrates,
inhibitors and inducers of cytochrome P450, UGT and other drug
metabolizing enzymes and drug transporters. The company offers a variety
of in vitro contract studies for drug candidate evaluation, as
well as an extensive selection of products for drug metabolism research.
XenoTech's product selection includes a wide-range of high quality
standard reagents, from subcellular fractions and hepatocytes to
recombinant enzymes, substrates and metabolites. The company can also
prepare and deliver custom-designed products and services in response to
client requests. XenoTech is based in Lenexa, Kansas, USA and has
approximately 100 employees. For additional information, please refer to
the company's website at http://www.xenotechllc.com
or call +1 (913) 438-7450.

About Provectus Biopharmaceuticals, Inc.

Provectus Biopharmaceuticals specializes in developing oncology and
dermatology therapies. Its novel oncology drug PV-10 is designed to
selectively target and destroy cancer cells without harming surrounding
healthy tissue, significantly reducing potential for systemic side
effects. Its oncology focus is on melanoma, breast cancer and cancers of
the liver. The Company has received orphan drug designations from the
FDA for its melanoma and hepatocellular carcinoma indications. Its
dermatological drug PH-10 also targets abnormal or diseased cells, with
the current focus on psoriasis and atopic dermatitis. Provectus has
recently completed Phase 2 trials of PV-10 as a therapy for metastatic
melanoma, and of PH-10 as a topical treatment for atopic dermatitis and
psoriasis. Information about these and the Company's other clinical
trials can be found at the NIH registry, www.clinicaltrials.gov.
For additional information about Provectus please visit the Company's
website at www.pvct.com
or contact Porter, LeVay & Rose, Inc.

FORWARD-LOOKING STATEMENTS: The forward-looking statements contained
herein are subject to certain risks and uncertainties that could cause
actual results to differ materially from those reflected in the
forward-looking statements. Readers are cautioned not to place undue
reliance on these forward-looking statements, which reflect management's
analysis only as of the date hereof. The company undertakes no
obligation to publicly revise these forward-looking statements to
reflect events or circumstances that arise after the date thereof.